Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07306754 | A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of ABBV-243 in Healthy Adults. | PHASE1 | RECRUITING | 66 | — | — | Dec 17, 2025 | May 1, 2027 | Jan 12, 2026 | 1 | United States |
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Maximum observed serum concentration (Cmax) of ABBV-243
Area under the serum concentration-time curve (AUC) from time 0 to the time of last measurable concentration (AUCt) of ABBV-243
AUC from time 0 to infinite time (AUCinf) of ABBV-243
Terminal phase elimination rate constant of ABBV-243
Terminal phase elimination half-life of ABBV-243
Confirmed Positive ADA Results.
| Arm | Type | Description |
|---|---|---|
| Group 1: ABBV-243 or Placebo | EXPERIMENTAL | Participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent, on Day 1 |
| Group 2: ABBV-243 or Placebo | EXPERIMENTAL | Participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent, on Day 1 |
| Group 3: ABBV-243 or Placebo | EXPERIMENTAL | Participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent, on Day 1 |
| Group 4: ABBV-243 or Placebo | EXPERIMENTAL | Participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent. on Day 1 |
| Group 5: ABBV-243 or Placebo | EXPERIMENTAL | Participants will receive either a single subcutaneous (SC) dose of ABBV-243, or the placebo equivalent, on Day 1 |
| Group 6: ABBV-243 or Placebo | EXPERIMENTAL | Participants will receive either a single subcutaneous (SC) dose of ABBV-243, or the placebo equivalent, on Day 1 |
| Group 7: ABBV-243 or Placebo | EXPERIMENTAL | Han Chinese participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent. on Day 1 |
| Group 8: ABBV-243 or Placebo | EXPERIMENTAL | Japanese participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent. on Day 1 |
| Name | Type | Description |
|---|---|---|
| ABBV-243 | DRUG | Intravenous (IV) Infusion |
| Placebo | DRUG | Intravenous (IV) Infusion |
Inclusion Criteria: * Individuals between 18 and 60 years of age inclusive at the time of Screening. * BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenth's decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters. * Females, Non-Childbearing ...